Sr Quality Engineer - New Product Development
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Must Have: Minimum Requirements
You must hold a minimum of a Bachelor’s degree in Mechanical or Bio-Medical Engineering, Math, Physical Science, or other related field with 4+ years of experience of developing complex electro-mechanical and/or robotic systems in a regulated industry.
Nice to Have
- Experience in design, manufacturing or quality engineering position (medical device experience preferred). 3 years of experience can be substituted for an Advanced degree in a related discipline.
- Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing.
- Statistical Quality Control/Statistical Process Control, Design of Experiments, Failure Mode and Effects Analysis.
- Experience in a regulated environment (FDA, ISO, etc.)
- Good communication skills, both written and oral and must be computer literate.
- Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 14971, ISO 13485 requirements.
- In-depth knowledge and experience in the use analytical tools and methods, including statistics (Minitab preferred), DOE and the use of computer/software packages related to design and development.
- ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)
- Six Sigma Green belt or Black Belt certified
- Geometric Dimension and Tolerance (GD&T)
- Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.
WORKING CONDITIONS:
• Standard office setting, surgical lab, operating room, pilot lab, external research organizations, supplier visits
• Distributed R&D teams
• Some travel may be required, mostly to Boston, MA
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EEO
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
